Echogenic Article with Compound Indentations

ABSTRACT

The present invention provides an article or an interface having a distribution of a first partially spherical indentation and at least a second partially spherical indentation contained within the first indentation to form a multi-component or “compound” shape that is referred to as a “compound” or “nested” dimples or indentations. These compound dimples or indentions may be concentric and are etched or otherwise formed into a surface or interface of an article to enhance the ultrasonic imaging. Exemplary articles may be needles of the type used to conduct nerve blocks or the interface may be the surface of such a needle, cannula, catheter, catheter tip or similar article.

RELATED APPLICATIONS

This application claims the benefit of priority from U.S. ProvisionalApplication No. 61/837,455 filed on Jun. 20, 2013 and is a continuationof U.S. application Ser. No. 14/308,038 filed on Jun. 18, 2014, now U.S.patent Ser. No. 10/076,307 and U.S. application Ser. No. 16/106,878filed on Aug. 21, 2018, all of which are incorporated by referenceherein in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to echogenic devices and methodsand particularly to echogenic devices, material and methods, which amongother applications may be used with medical devices that are insertableinto a medium such as biological tissue and imageable with sonic imagingequipment

BACKGROUND

Ultrasonic imaging in the medical field is widely used for a variety ofapplications. In addition to imaging physiological structures and tissuesuch as organs, tumors, vessels, and the like, it is often desirable fora physician or technician to have an image of a medical device which hasbeen inserted into the tissue or passageway of a patient. The types ofdevices which are surgically sterilized and inserted into patients aremany. Typical examples include: needles, catheters and a variety ofother medical products such as stents, dilators, pacing leads,introducers, angiography devices, angioplasty devices, pacemakers,in-patient appliances such as pumps and other devices. Variousapproaches have been used to enhance ultrasonic imaging by modifying thereflective surface characteristics of these devices.

U.S. Pat. No. 5,081,997 to Bosley, Jr. et al, for “Echogenic Devices,Material and Method” discloses a device such as a needle that includesan interface having a shape that is formed with a dimension that is lessthan a wavelength of the incident sonic beam. According to Bosley, Jr.et al., the shape includes a dimension such as a radius of curvaturewhich is much less than the wavelength of the sonic beam. The interfacemay include the outside surface a device or article or material. Thatsurface has a plurality of partially spherical indentations forproducing a scattered component of the image in response to the incidentbeam. This image is produced regardless of the incident beam angle ofwhich conventional devices depend for producing a reflected orconstructive interference image. The scattered component of the image isproduced when the radius of the partially spherical indentations or adimension of another geometric shape or surface are much less than thewavelength of the incoming sonic beam.

Conventional recesses or dimples frequently have faces, bottoms andsides that are generally flat. For example, FIGS. 1-4 arephotomicrographs illustrating a portion of an echogenic region from anEchoTip® needle available from Cook Medical, Bloomington, Ind. As can beseen in these photomicrographs, the echogenic region contains recessesor dimples having generally flat bottoms and sides that are generallyperpendicular to the needle surface and to the recess or dimple bottom.The recess or dimple bottom has a small groove which is believed to bean artifact of machining.

U.S. Patent Application Publication No. 2004/0249288 A1 to Ichikawa for“Ultrasonic Puncture Needle” discloses a device including an array ofdoughnut shaped recesses having a center portion remaining as aprotrusion. According to US Publication No. 2004/0249288 A1, therecesses are also formed with faces, bottoms and sides being generallyflat so to obtain reflection echoes with a great intensity for theincident ultrasonic waves with a shallow incident angle.

While the approaches described in U.S. Pat. No. 5,081,997 and U.S.Publication No. 2004/0249288 A1 have shown promise, improvements havebeen sought that would result in an interface that provides enhancedultrasonic imaging, in a manner that is inexpensive to manufacture, andsimple and reliable to use.

SUMMARY OF THE INVENTION

In response to the difficulties and problems discussed herein, thepresent invention provides an article or an interface having adistribution of a first partially spherical indentation and at least asecond partially spherical indentation contained within the firstindentation. Such a multi-component or “compound” shape may be referredto as a “compound” or “nested” dimples or indentations. These “compounddimples” or indentions are etched or otherwise formed into a surface orinterface of an article to enhance the ultrasonic imaging. Exemplaryarticles may be needles of the type used to conduct nerve blocks or theinterface may be the surface of such a needle, cannula, catheter,catheter tip or similar article.

Generally speaking, the dimple or indention is composed of at least afirst partially spherical indentation and a second partially sphericalindentation contained within the first indentation. The presentinvention contemplates compound dimples that may include at least afirst partially spherical indentation and a second and third (or more)partially spherical indentation contained within the first indentation.Alternatively and/or additionally, the present invention contemplatescompound dimples that may include at least a first partially sphericalindentation and a second partially spherical indentation containedwithin the first indentation and a third (or more) partially sphericalindentation contained within the second indentation.

In an aspect of the invention, the first (or major) partially sphericalindentation or “dimple” may have a diameter ranging from aboutapproximately 0.003 to approximately 0.006 inch. The second (or minor)partially spherical indentation or “internal dimple” may have a diameterof up to about 0.0025 inch. For example, the second (or minor) partiallyspherical indentation or “internal dimple” may have a diameter of fromabout 0.0005 to about 0.0025 inch. Additional partially sphericalindentations contained within the first partially spherical indentationand/or the second partially spherical indentation should be smaller. Inan aspect of the invention, the spacing between the edges of the majorpartially spherical indentations or dimples may be about 0.004 inchapart. In another aspect of the invention, the depth of the sphericalindentations may be from about 0.0005 to about 0.005 inch.

The “compound” structure of nested partially spherical indentations ordimples may be manufactured in a process using a laser. The second (orminor) partially spherical indentations or dimples are generated duringthe manufacturing process by spatter, displacement of metal and otherphenomena. This “compound” or nested structure is thought to increaseRayleigh Scattering of the ultrasonic wave which significantly increasesthe echogenicity of an article (e.g., a needle) having a distribution ofthese “compound dimples”. When the indentation is substantially smallerthan the wavelength of the ultrasonic beam, Rayleigh Scattering occurs.

These and other features and advantages of the invention will becomemore apparent to one skilled in the art from the following descriptionand claims when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be better understood by reading the DetailedDescription of the invention with reference to the accompanying drawingfigures, in which like reference numerals denote similar structure andrefer to like elements throughout, and in which:

FIG. 1 is a scanning electron photomicrograph at 50× linearmagnification of a surface illustrating an article having a distributionof conventional dimples or recesses.

-   -   The article is the shaft of a cannula or needle.

FIG. 2 is a scanning electron photomicrograph at 200× linearmagnification of a surface illustrating an article having a distributionof conventional dimples or recesses.

FIG. 3 is a scanning electron photomicrograph at 500× linearmagnification of a surface illustrating a detail of a conventionaldimple or recess.

FIG. 4 is a scanning electron photomicrograph at 200× linearmagnification of a surface illustrating an article having a distributionof conventional dimples or recesses.

FIG. 5 is a scanning electron photomicrograph at 50× linearmagnification of a surface illustrating an article having a distributionof exemplary compound or nested dimples; that is, a first partiallyspherical indentation and at least a second partially sphericalindentation contained within the first indentation. The article is theshaft of a cannula or needle.

FIG. 6 is a scanning electron photomicrograph at 200× linearmagnification of a surface illustrating an article having a distributionof exemplary compound or nested dimples; that is, a first partiallyspherical indentation and at least a second partially sphericalindentation contained within the first indentation.

FIG. 7 is a scanning electron photomicrograph at 500× linearmagnification of a surface illustrating a detail of an exemplarycompound or nested dimple; that is, a first partially sphericalindentation and at least a second partially spherical indentationcontained within the first indentation.

FIG. 8 is a scanning electron photomicrograph at 200× linearmagnification of a surface illustrating an article having a distributionof exemplary compound or nested dimples; that is, a first partiallyspherical indentation and at least a second partially sphericalindentation contained within the first indentation.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides an article or an interface having asurface that includes distribution of a first partially sphericalindentation and at least a second partially spherical indentationcontained within the first indentation. An exemplary configuration isillustrated in FIGS. 5-8 and such a multi-component or “compound” shapemay be referred to as a “compound” or “nested” dimples or indentations.These “compound dimples” or indentions are etched or otherwise formedinto a surface or interface of an article to enhance the ultrasonicimaging. Exemplary articles may be needles of the type used to conductnerve blocks or the interface may be the surface of such a needle,cannula, catheter, catheter tip or similar article.

Referring more particularly to FIG. 7, the dimple or indention iscomposed of at least a first partially spherical indentation which isillustrated in the photomicrograph as the larger or major partiallyspherical indentation having a first radius of curvature. Fullycontained within this first, larger or major partially sphericalindentation is a second partially spherical indentation having a secondradius of curvature. As can be seen in the FIGS. 5-8 and particularly inFIG. 7, the first partially spherical indentation has a larger radius ofcurvature than the second partially spherical indentation. In otherwords, the first partially spherical indentation has a lower curvatureor is relatively flatter than the second partially sphericalindentation—and the second partially spherical indentation has a highercurvature or is relatively steeper than the first partially sphericalindentation.

According to an aspect of the invention, the first partially sphericalindentation and the second partially spherical indentation areconcentric. That is, the two indentations have a common center point andmay be described as concentric circles when viewed from directlyoverhead as shown in FIG. 6.

In an aspect of the invention, the compound or nested dimples may beconfigured so the first partially spherical indentation contain orinclude a second and third (or more) partially spherical indentation—andthese second or third or more partially spherical indentations will havea higher curvature will be relatively steeper than the first partiallyspherical indentation. Alternatively and/or additionally, the compoundor nested dimples that may include at least a first partially sphericalindentation and a second partially spherical indentation containedwithin the first indentation and a third (or more) partially sphericalindentation contained within the second indentation.

In an aspect of the invention, the first (or major) partially sphericalindentation or “dimple” may have a diameter ranging from about 0.003 toabout 0.006 inch (about 76 micrometers to about 152 micrometers). Thesecond (or minor) partially spherical indentation or “internal dimple”may have a diameter of up to about 0.0025 inch (about 63 micrometers).For example, the second (or minor) partially spherical indentation or“internal dimple” may have a diameter of from about 0.0005 to about0.0025 inch (about 12 micrometers to about 63 micrometers). Additionalpartially spherical indentations contained within the first partiallyspherical indentation and/or the second partially spherical indentationshould be smaller. It is contemplated that the first (or major)partially spherical indentations or “dimples” may have diameters rangingfrom about 0.003 to about 0.006 inch (about 76 micrometers to about 152micrometers) and the second (or minor) partially spherical indentationsor “internal dimples” may have diameters of up to about 0.0025 inch(about 63 micrometers). That is, the diameters of the first and/or thesecond partially spherical indentations may be non-uniform orpolydisperse.

In an aspect of the invention, the spacing between the edges of separateadjacent major partially spherical indentations or dimples may be about0.002 inch to about 0.01 inch apart (about 51 micrometers to about 254micrometers apart). This distance is the closest distance betweenseparate compound dimples as illustrated in FIGS. 5 and 6. For example,the distance between the edge of one dimple and the edge of the nextclosest dimple may be about 0.004 inch apart (about 102 micrometersapart). In yet another aspect of the invention, the depth of thepartially spherical indentations may be from about 0.0005 to about 0.005inch (from about 12 micrometers to about 126 micrometers). That is, thedepth of the partially spherical indentations is the depth at thedeepest portion of the compound or nested structure.

The “compound” structure of nested partially spherical indentations ordimples may be manufactured in a process using a laser. The second (orminor) partially spherical indentations or dimples are generated duringthe manufacturing process by spatter, displacement of metal and otherphenomena. This “compound” or nested structure is thought to increaseRayleigh Scattering of an ultrasonic beam which significantly increasesthe echogenicity of an article (e.g., a needle) having a distribution ofthese “compound dimples”. When the indentations are substantiallysmaller than the wavelength of the ultrasonic beam, Rayleigh Scatteringoccurs. It is thought that the “compound” structure of nested partiallyspherical indentations help generate Rayleigh

Scattering and enhance ultrasonic imaging regardless of the incidentultrasonic beam angle.

As an example, a distribution of a first partially spherical indentationand at least a second partially spherical indentation contained withinthe first indentation (i.e., compound or nested partially sphericalindentations or dimples) may be etched or manufactured along the lengthor only a portion of a metal needle of the type used to carry outperipheral nerve blocks. Such an exemplary configuration is illustratedin the scanning electron photomicrograph of FIG. 5. The distribution ofthe compound or nested “dimples” may be formed onto a cannula or needleblank. The cannula or needle blank can be further configured with aneedle tip—also called a cutting tip. In the manufacturing process,forming the dimples first and added the cutting tip in a subsequent stepallows the dimples to be present at or near the cutting tip of theneedle. This is particularly advantageous because the compound or nesteddimples provide enhanced ultrasonic imaging at or very near the tip ofthe needle or cannula. The present invention is readily distinguishableover more conventional recesses or dimples having generally flat bottomsand sides that are generally perpendicular to the needle surface and tothe recess or dimple bottom as illustrated in FIGS. 1-4. In thesephotomicrographs, the recess or dimple bottom has a small groove whichis believed to be an artifact of machining. As can be seen in thephotomicrographs of FIGS. 1-4 and particularly in FIG. 3, the dimplesare relatively deep compared to their diameters. Although it is believedto provide good reflectivity and scattering, this configuration isrelatively difficult to manufacture. For example, the dimple depicted inFIG. 3 has a diameter of approximately 80 micrometers and a depth ofapproximately 40 micrometers.

As seen in the photomicrographs of FIGS. 5-8 and particularly in FIG. 7,the dimples of the present invention are much shallower than theconventional dimples shown in FIGS. 1-4. Shallower dimples aresignificantly easier to manufacture but are generally thought to haveless reflectivity. However, the “compound” or nested structure isthought to increase Rayleigh Scattering of an ultrasonic beam. It isbelieved that the “compound” or nested structure significantly increasesthe echogenicity of the shallow dimple such that a shallow, relativelyeasy to manufacture dimple provides comparable reflectivity ofultrasonic beams as a relatively deep dimple. Accordingly, a surface(e.g., a needle) having a distribution of these easy to manufacture“compound dimples” has reflectivity that compares favorably to thedifficult to manufacture deep dimples.

In addition, while the disclosure has been described in detail withrespect to specific embodiments thereof, it will be apparent to thoseskilled in the art that various alterations, modifications and otherchanges may be made to the disclosure without departing from the spiritand scope of the present disclosure. It is therefore intended that theclaims cover all such modifications, alterations and other changesencompassed by the appended claims.

What is claimed is:
 1. A method of manufacturing an echogenic article,the article comprising at least one of a needle, a cannula, a catheter,or a catheter tip, the method comprising: providing the article having asurface; forming a distribution of a plurality of first partiallyspherical indentations into the surface of the article, each of theplurality of first partially spherical indentations defining a firstinner surface having a first radius of curvature; forming a secondpartially spherical indentation within each of the plurality of firstpartially spherical indentations, each of the plurality of secondpartially spherical indentations defining a second inner surface havinga second radius of curvature, each of the second partially sphericalindentations contained within one of the first partially sphericalindentations, the first radius of curvature being larger than the secondradius of curvature such that each of the plurality of the firstpartially spherical indentations is flatter than the each of theplurality of second partially spherical indentations.
 2. The method ofclaim 1, wherein a spacing between edges of separate adjacent firstpartially spherical indentations ranges from about 50 micrometers toabout 260 micrometers.
 3. The method of claim 2, wherein the spacingbetween edges of separate adjacent first partially sphericalindentations is up to about 100 micrometers.
 4. The method of claim 1,wherein a depth of each of the plurality of first and second partiallyspherical indentations ranges from about 10 micrometers to about 130micrometers.
 5. The method of claim 1, wherein a first diameter of thefirst partially spherical indentations and/or a second diameter of thesecond partially spherical indentations are non-uniform.
 6. The methodof claim 1, wherein the each of the first partially sphericalindentations is concentric with one of the second partially sphericalindentations.
 7. The method of claim 1, further comprising a pluralityof third partially spherical indentations contained within each of thesecond partially spherical indentations.
 8. The method of claim 1,wherein each of the plurality of first partially spherical indentationscomprises a first diameter and each of the plurality of second partiallyspherical indentations comprises a second diameter, the first diameterof the first partially spherical indentation ranging from 70 micrometersto 160 micrometers, the second diameter of the second partiallyspherical indentation ranging from 10 micrometers to 70 micrometers.